NCT04942223

Guided Bone Regeneration With Custom Made Meshes

Guided Bone Regeneration With Custom Made Meshes in the Dental Rehabilitation of Three Dimensional and Extended Defect of the Jaws.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final results. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.

Detailed description

The implant-borne rehabilitation of three-dimensional and extended alveolar defects is not simple in any case: anatomic and prosthetic demands often require bone reconstructive procedures. Up to date, we can entirely virtually simulate our treatment .The design and printing of a customized mesh mimicking the ideal reconstruction eliminate the intra-operative handling and trimming, with reduced surgical timings and minimal stress for the soft tissues. The aim is to verify if virtual planning with a customized scaffold could improve the predictability of a complex bone reconstruction in terms of bone reconstruction and implant results. Twenty patients underwent a guided bone regenerative procedure with the application of a virtually projected customized mesh as containment and stabilizer of particulate bone graft. The entity of bone volume reconstructed after healing were digitally analysed on radiological imaging and expressed in volumetric data and in percentage of what planned before the operation. This datum was correlated with predictors variables potentially affecting the final result: six months at least after surgery, a new cone-beam CT was taken;the pre-and postoperative CT datasets were converted into three-dimensional models and digitally aligned; the reconstructed bone volumes (RBV) were calculated according to the planned bone volumes (PBVs), outlining the areas under the mesh. These values were correlated with complications, atrophies' location and the entity of virtually planned bone volume. As secondary outcome the implant results after the prosthetic loading was evaluated in terms of survival, success and complication.

Conditions

• The Presence of Horizontal and Vertical Alveolar Defects in Both Jaws, Inadequate for the Placement of at Least Two Fixtures, Even ≤6 mm Long Ones

Interventions

Type	Name	Description
DEVICE	guided bone regeneration	After local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely. The flaps were coronally extended to assure a complete closure with a passive suture above the titanium. Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone. The bone block was milled and mixed with freeze-dried. The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders. Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured. Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days.

Timeline

• Start date: 2013-04-09
• Primary completion: 2018-05-15
• Completion: 2020-12-31
• First posted: 2021-06-28
• Last updated: 2021-06-28